At least 2 years
This role is STARs-friendly: Skilled Through Alternative Routes.
73% STARs in role.
Job Title: Quality Investigator
Job Description
As a Quality Investigator, you will be responsible for authoring and managing Quality Assurance Reports (QARs) and conducting deviation investigations related to manufacturing operations and process execution. You will play a pivotal role in supporting investigations for batch record discrepancies, process deviations, and manufacturing execution issues, while ensuring equipment or material impacts on operations are thoroughly examined.
Responsibilities
- Lead root cause analysis using site-approved methodologies and ensure conclusions are accurate and defendable.
- Partner directly with Manufacturing, MSAT, Engineering, QA, and Operations leadership to gather accurate investigation details.
- Review and interpret batch records, manufacturing documentation, production logs, alarms, process data, SOPs, work instructions, and training records.
- Develop impact assessments and CAPAs aligned with operational risk and regulatory expectations.
- Ensure investigations are completed on time, accurate, and compliant with site procedures and GMP standards.
- Support regulatory inspections, internal audits, and quality metric reviews related to operations deviations.
Essential Skills
- Bachelor’s degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience.
- 2+ years of experience supporting operations-based deviations and quality investigations in a GMP manufacturing environment.
- Proven ability to independently write and close investigations tied to manufacturing processes.
- Strong understanding of batch record review, manufacturing workflows, and GMP documentation practices.
- Experience working in electronic quality systems (eQMS).
- Excellent technical writing, critical thinking, and stakeholder communication skills.
Additional Skills & Qualifications
- Direct experience supporting aseptic or sterile manufacturing operations.
- Prior experience at a high-volume pharmaceutical manufacturing site.
- Experience supporting regulatory inspections or inspection readiness activities.
- Experience in Manufacturing, MSAT, or Operations Quality.
Work Environment
This role is situated in a pharmaceutical manufacturing environment with an office area. You will be supporting critical backlog work to aid in getting products to patients on time, which are mission-critical to our healthcare system.
Job Type & LocationThis is a Contract position based out of Raleigh, NC.
Pay and BenefitsThe pay range for this position is $60.00 - $80.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
This is a fully onsite position in Raleigh,NC.
Application DeadlineThis position is anticipated to close on May 22, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006015791
